Prescription drug · ANDA
Ofloxacin NDC 50090-7264
Ofloxacin 3 mg/mL · Solution/ drops · Ophthalmic · A-S Medication Solutions
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 50090-7264-0 | 50090726400 | 1 BOTTLE, DROPPER in 1 CARTON (50090-7264-0) / 10 mL in 1 BOTTLE, DROPPERMarketed from Oct 7, 2024 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Ofloxacin
- Generic name (nonproprietary)
- ofloxacin
- Active ingredients
- Ofloxacin — 3 mg/mL
- Dosage form
- Solution/ drops
- Route
- Ophthalmic
- Labeler
- A-S Medication Solutions
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076622
- Marketing start
- Listing expires
- Other FDA classes
- Quinolones (Chemical structure)
- Identifiers
- Product ID 50090-7264_ff37e0c3-e71b-4cd6-8242-cc71c3374af6SPL ID ff37e0c3-e71b-4cd6-8242-cc71c3374af6SPL set ID 1838671d-e312-442a-b0bc-6702d6a8965cRxCUI 312075UNII A4P49JAZ9H
- Pharmacologic class
- Quinolone Antimicrobial
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Ophthalmic products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N450090726400followed by a unit qualifier and the quantityPackage 50090-7264-00. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Ofloxacin ophthalmic solution is indicated for the treatment of infections caused by susceptible strains of the following bacteria in the conditions listed below: CONJUNCTIVITIS: Gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Gram-negative bacteria: Enterobacter cloacae Haemophilus influenzae Proteus mirabilis Pseudomonas aeruginosa CORNEAL ULCERS: Gram-positive bacteria: Staphylococcus aureus Staphylococcus epidermidis Streptococcus pneumoniae Gram-negative bacteria: Pseudomonas aeruginosa Serratia marcescens* Anaerobic species: Propionibacterium acnes *Efficacy for this organism was studied in fewer than 10 infections…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076622
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | A-S Medication Solutions | 50090-1744 |
| Ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | Bausch & Lomb Incorporated | 24208-434 |
| Ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | Proficient Rx LP | 63187-268 |
| Ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-2254 |
| Ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | NuCare Pharmaceuticals,Inc. | 68071-2265 |
| Ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | Preferred Pharmaceuticals, Inc. | 68788-7693 |
| Ofloxacin | Ofloxacin 3 mg/mL | Solution/ dropsOphthalmic | REMEDYREPACK INC. | 70518-3573 |